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Effect of Metformin in Individuals With Type 2 Diabetes According to SLC16A11 Risk Variant Carrier Status

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective observational study will evaluate whether the SLC16A11 risk variant influences the response to metformin in adults with type 2 diabetes. Participants will be classified as carriers or noncarriers and followed for 6 months while receiving extended-release metformin titrated to the maximum tolerated dose, between 1,500 and 2,250 mg/day. The primary outcome is the change in glycated hemoglobin, with additional assessment of seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to include 154 participants to compare treatment response between both genetic groups and explore the potential value of a more personalized therapeutic approach.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male and female participants

• Aged 18 to 65 years

• Diagnosis of type 2 diabetes

• Estimated glomerular filtration rate (eGFR) \>60 mL/min

• Glycated hemoglobin (HbA1c) ≤8%

• Participants who are treatment-naïve, receiving metformin monotherapy, or receiving dual glucose-lowering therapy

• Participants who agree to take part in the study

Locations
Other Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
RECRUITING
Mexico City
Contact Information
Primary
Paloma Almeda Valdés, MD, PhD
paloma.almedav@incmnsz.mx
525554870900
Time Frame
Start Date: 2020-09-23
Estimated Completion Date: 2027-12
Participants
Target number of participants: 154
Treatments
SLC16A11 Risk Variant Carriers
Individuals with type 2 diabetes who carry the SLC16A11 risk variant and receive metformin treatment as part of their clinical management.
SLC16A11 Risk Variant Noncarriers
Individuals with type 2 diabetes who do not carry the SLC16A11 risk variant and receive metformin treatment as part of their clinical management.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

This content was sourced from clinicaltrials.gov

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